BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1161673 · Received September 15, 2008

    Report

    Report Number
    6000034-2008-00525
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 20, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, DUE TO AN INFECTION, THE PT'S DEVICE WAS EXPLANTED IN '08 AFTER SEVERAL MONTHS OF TREATMENT WITH IV ANTIBIOTICS. THE PT HAS A FUNCTIONING IMPLANT IN THE CONTRALATERAL EAR. REIMPLANTATION IS PLANNED IN APPROX SIX MONTHS BUT HAD NOT BEEN SCHEDULED AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention